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Kalytera Announces Initiation of Study KAL-07 – Food Effect Study
Kalytera Announces Initiation of Study KAL-07 – Food Effect Study.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\nSAN FRANCISCO and TEL AVIV, Israel, March 06, 2019 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the \"Company\" or \"Kalytera\") today announced that it has initiated a food effect study (“Study KAL-07”), as part of its lead product development program evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”).\n Study KAL-07 is being initiated pursuant to written guidance received from U.S. Food and Drug Administration (the “FDA”).  The FDA is requiring that the Company complete a study in healthy volunteers to assess the effect of food intake on the absorption of oral CBD, prior to initiation of a Phase 3 registration study. The initiation of Study KAL-07 will satisfy this FDA requirement, and bring the Company’s program in prevention of acute GVHD another step closer to initiation of the pivotal registration study. “Study KAL-07 is an important part of our overall Phase 2 program,” stated Robert Farrell, President and CEO of Kalytera. “Our goal is to complete all prerequisite work required by the FDA so that we can initiate registration testing as soon as possible. We anticipate that we will complete Study KAL-07 by the end of the second quarter this year.” Kalytera’s Phase 2 program in prevention of GVHD consists of three separate clinical studies: (1) Study KAL-05; (2) Study KAL-07; and (3) Study KAL-08. Study KAL-05Study KAL-05 is the Company’s ongoing open label, multicenter study to evaluate multiple doses of CBD for the prevention of acute GVHD following allogeneic hematopoietic cell transplantation, commonly referred to as bone marrow transplantation. The study is evaluating the PK profile, safety, and efficacy of CBD at doses of 75, 150, and 300 mg twice daily (“BID”).  It is anticipated that Study KAL-05 will be complete later this year, and will provide support for the planned Phase 3 registration study required for regulatory approval by the FDA. Study KAL-07Study KAL-07, the “food effect study”, is a double blind, randomized, two period, two treatment, fixed sequence, crossover  (fed versus fasted) study to evaluate the effect of food on the pharmacokinetics of CBD, along with robust ECG monitoring in 32 health...